The Winnipeg Free Press is reporting that Regenetek, a Canadian stem cell company, faces serious charges related to for-profit stem cell therapies. (Update: a followup story in the Free Press has been published).

A very thorough article in the newspaper by Melissa Martin and Mary Agnes Welch reports that a “researcher” at the company named Doug Broeska (picture above from LinkedIn) who ran a stem cell trial for Multiple Sclerosis (MS), had faked credentials and overstated results of the trial.

Broeska, who apparently patients referred to as “Dr. Doug”, not only did not have an MD, but also lacked a Ph.D. In fact, Broeska’s previous experience was in lumber, which is long way from stem cells or MS or really anything medical or scientific.

Regenetek and Broeska ran a clinical trial based on stem cells for MS in Pune, India. The Free Press has investigated the trial and found numerous concerns:

“A Free Press investigation has found Broeska fabricated his credentials, including his PhD, and overstated the effects of the stem-cell treatment, for which he often charged desperately ill people $45,000. Four patients spoke to the Free Press on the record, saying they got no benefit from the treatment, got none of the followup common in clinical trials — such as MRIs or physical acuity tests — and believe they are victims of fraud.”

And patients who later complained or raised concerns were then reportedly the subject of verbal attacks:

“Patients who were once ardent supporters were attacked as saboteurs or shills for “Big Pharma” and threatened with removal from the study after they asked questions.”

Unfortunately this sounds a lot like what happens at some stem cell clinics right here in the US as well including some offering “treatments” for MS. Further, I myself have been called a friend of Big Pharma numerous times by fans of dubious stem cell clinics in the US. The marketing of the Regenetek clinical trial (a practice banned in Canada) also sure sounds similar to the approach used by many US stem cell clinics:

“Marketing or promoting clinical trials is banned in Canada. But, Broeska repeatedly asked patients to post positive experiences on an active “patient-run” Facebook page and later hired a marketing expert to create professional-quality videos showing patients who experienced significant recoveries. Those videos are available on his website, on YouTube and on Facebook. Of the nine patients who spoke to the Free Press about their treatment, nearly all said the videos helped convince them Regenetek’s stem-cell treatment was credible.”

The Royal Canadian Mounted Police (RCMP) has reportedly received patient complaints about Regenetek and their stem cell therapies:

“At least two of Regenetek’s former patients have complained to the RCMP, and sources say the Canada Revenue Agency is investigating, though CRA officials would not confirm that. Last week, Regenetek’s website, Broeska’s LinkedIn page and a “patient-run” Facebook group were taken down.”

The newspaper also published a letter from an ethics oversight committee in Pune that ordered Broeska to stop the clinical trial because he had “significant potential to jeopardize patient safety and patient rights”.

The newspaper article got in touch with Broeska for comment and he claimed it was all a “mix up”:

“Broeska, who is in the Caribbean on business for several days, said in an email he was terminated only because it was decided to have a local principal investigator stationed in India. He also said the concerns about the clinical trial related to research at another Indian hospital entirely.”

That’s hard to imagine that such a mixup could occur, but let’s see how this plays out.

The Free Press continued to find evidence of problems with this trial as it investigated: “In several emails to patients and in the company’s promotional material, Broeska claims he is a member of the society. The ICMS’s executive director, Reed Davis, said he could find no evidence Broeska was or is a member.”

Apparently there were claims of an IRB approval from ICMS as well and then later from the US-based International Cell Surgical Society (ICSS), a company that can issue IRBs (e.g. it seems to have issued IRBs to one of the largest stem cell clinic chains in the US, Cell Surgical Network).

The Free Press talked to David Audley as well:

“In a phone interview Monday, Regenetek spokesman David Audley said the stem-cell treatments are legal and ethical in India, and the company is now seeking similar ethics approval in North America.

“What’s going on with these treatments right now is perfectly legal in the jurisdiction where it’s happening,” said Audley, noting the clinical trial has approval from the Pune hospital’s ethics board.

Audley refused to provide the inclusion and exclusion criteria for the clinical trial or what followup is mandated.

“I’m not going to go into the specifics of the clinical study, because it’s an ongoing clinical study,” said Audley. “We’re not going to go into the details about the structure of our clinical trials, nor are we going to go into detail about how the clinical study is being managed or the outcomes are being collected. That’s all part of Regenetek’s protocol.”

In the end this Regenetek trial sure sounds like it mostly about making money at patient’s expense (quite literally). Unfortunately this story is all too familiar in many respects for how the for-profit, dubious stem cell industry operates globally including in the US.

11 Comments

I called your office and tried to tell you about this; you chose NOT to return my call. Now you post this AFTER I’ve already posted MULTIPLE links in multiple LI groups? Interesting. I’m SURE my comment will not be approved for posting.

Geeze… calm down… Start your own blog if you want the word to get out faster. Do you think a leading researcher has time to respond to everyone? The story is here now. Seems a bit like you simply want personal validation. So I will give you some. GREAT JOB for finding this story!

I don’t enjoy negative things happening in the stem cell world, but it is important to discuss both the UPs and the DOWNs. This blog provides a means to facilitate discussion between all stakeholders. Everyone is welcome to comment, I often invite those who might strongly disagree with me to guest post or do a Q&A interview.

Very interesting! The CCSVI page mentions that they characterize the cells before implantation (like the Great Britain study did). I wonder if this is actually true and if they give you a printout of the “MSCness” of your cells before injecting them back into you. As for Connick et al., one thing I wonder about is that they mention that they expanded the cells for an average of 24 days to get enough to inject and that they characterized the cells…but I wonder whether they characterized the cells after the 24 days (i.e., after what must have been at least 6-8 passages) or whether they characterized them towards the beginning of culture…

If I understood things correctly, the Regenetek treatment is based upon a total timeframe of 14 days which was inconsistent with the time frame for culture.

The post-treatment followup didn’t mention MRI (as far as I could tell) whereas the published British work seemed to be much more thorough than what Regenetek was even claiming to do.

As a layperson, I’d always tell other laypeople to at least check out the doctors practice history and to also check out the published references that doctors base their experimental treatment upon, even if you can’t fully understand them. If there are lots of similar publications and if your doctor was an author on some of them or is at least published in the field, then that lends credibility. Otherwise, no credibility, run a mile.

The fact that Regenetek didn’t properly identify and link to the references that they mentioned is a major warning — especially when an article is open access — that Regenetek may be dealing in half truths…

Another thing that an educated layperson might do is to evaluate the literary merit of the Regenetek site. It looks like it was written by a 12 year-old (sorry for any offence to the young). I’ve known lots of smart kids but I wouldn’t let any of them stick needles into me…

Interesting. That means that they are likely implanting less cells than Connick et al. because less time is used to expand the cells, so fewer cells will be available for injection. At the same time, one big difference that could affect the amount of cells required is that Connick et al. used only intravenous delivery, whereas CCSVIU uses both intravenous and intrathecal (typically, fewer cells are applied intrathecally because of the smaller volume).

I totally agree with you about measures of credibility. I would also add that if a clinic cultured my cells ex vivo but then did not give me a complete, printed characterization of the cells they were going to inject into me, I wouldn’t even think of having it done.

As for the duration of cell expansion, I was mainly interested in Connick et al. because typically, the “MSCness” of MSCs decreases with the number of passages. This isn’t to say that higher-passage cells would not necessarily be useful- they may still secrete some useful substances- but it makes you wonder exactly what kind of cells are actually being injected. I just wish in their paper that they were more clear about whether the cells were characterized before or after the ex vivo expansion.